Name: 04/30048584 DC : DRAFT MAY 2004
Brand: BSI

BS EN ISO 11137-2 - STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE

Superseded date

29-06-2007

Published date

23-11-2012

Publisher

British Standards Institution

BS EN ISO 11137-2

Committee	CH/198
DocumentType	Draft
PublisherName	British Standards Institution
Status	Superseded
SupersededBy	BS EN ISO 11137-2:2015

ISO 11137-1:2006	Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11737-2:2009	Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO 11737-1:2006	Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
ISO 13485:2016	Medical devices Quality management systems Requirements for regulatory purposes
AAMI TIR27 : 1ED 2001	STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION STERILIZATION - SUBSTANTIATION OF 25 KGY AS A STERILIZATION DOSE - METHOD VD MAX
AAMI ST32 : 1991	GUIDELINE FOR GAMMA RADIATION STERILIZATION
ISO 11137-3:2017	Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control

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